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BioFire Receives FDA Clearance for the FilmArray® 2.0 System

26 February, 2015

New system delivers higher throughput, single database management and minimized footprint

Marcy l’Etoile, France – February 26, 2015 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular biology affiliate, received FDA clearance and CE-IVD marking of the FilmArray® 2.0 system. The system is expected to be commercially available by the end of March 2015. This clearance occurs in the very favorable context of the adoption of FilmArray® by clinical laboratories. Since its acquisition, BioFire has reported more than 60% organic growth in sales at December end.

FilmArray® 2.0 features higher throughput, allowing customers random access processing up to 175 samples in a day within a small footprint. FilmArray® 2.0 offers the same strengths of rapidity, ease-of-use, integration and accuracy that characterize the current FilmArray®. Each system accommodates 1 to 8 FilmArray® 2.0 units operated by a single computer. The system is also capable of connecting to Laboratory Information Systems.

“As we develop additional applications for the FilmArray® system, it is essential that customers are able to accommodate high throughput with as small of a footprint as possible,” said Randy Rasmussen, bioMérieux Corporate Vice President of Molecular Biology and CEO of BioFire Diagnostics. “We look forward to introducing the FilmArray® 2.0 system to clinical laboratories throughout the world and are excited for the expected benefits FilmArray®’s syndromic approach  will have on the fight against infectious diseases, antibiotic stewardship and more broadly on patient care and healthcare cost reduction.”

FilmArray® is a PCR* closed-system that integrates all molecular diagnostic steps including sample preparation, amplification, detection and analysis, with only two minutes of hands-on time and has a total run time of about an hour. As of today, the FilmArray® menu includes three FDA-cleared and CE-marked panels: the Respiratory Panel, the Blood Culture Identification Panel and the Gastrointestinal Panel. Additionally, BioFire has initiated studies for its Meningitis-Encephalitis Panel, with FDA submission expected this year.

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